FDA 510(k) Application Details - K050836

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K050836
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	SENTINEL CH. SRL PIAZZA ALBANIA 10 ROME 00153 IT Other 510(k) Applications for this Company
Contact	Maria E Donawa Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	DCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2005
Decision Date	08/08/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review